ObjectiveThe COVID-19 pandemic had a substantial impact on university students, including those in medical schools, with disruption in routine education causing significant psychological distress. ...The objective of this study was to evaluate the factors associated with psychological distress among medical students during the period of enforced home quarantine from March through May 2020.DesignA cross-sectional study.SettingOne Japanese medical school.Participants571 medical students.Primary and secondary outcome measuresSelf-administered electronic questionnaires including the K-6 scale for psychological distress, the Rosenberg Self-Esteem Scale (RSES) for self-esteem and the General Self-Efficacy Scale (GSES) for self-efficacy were distributed. To assess the determinant factor for psychological distress, variables such as sex, grade in school, living conditions, and RSES and GSES scores were evaluated in regression analysis.Results163 respondents (28.5%) scored ≥5 on the K-6 scale, indicating a significant degree of psychological distress. Logistic regression revealed that a higher score on RSES (p<0.001) and GSES (p<0.01) was an independent factor associated with lower levels of psychological distress. Multiple regression analysis focusing on students with a K-6 score ≥5 revealed that higher scores on RSES correlated with lower levels of psychological distress. By contrast, those with higher GSES scores also scored higher for indicators of psychological distress.ConclusionsThis study identified that self-efficacy and self-esteem were both influential factors for predicting psychological distress during the current COVID-19 pandemic. Medical schools should provide support for mental health and educational initiatives directed at enhancing self-esteem and self-efficacy, with a focus on improving personal resilience. In emergency situations, such as that faced in response to the COVID-19 pandemic, initial programmes might target students with higher levels of self-efficacy. By contrast, under routine situations, these efforts should be directed towards students with lower self-esteem as primary means to prevent depression.
Adenoid cystic carcinoma (ACC) is a major histological type of salivary gland cancer but an uncommon form of vulvar cancer. Salivary gland ACC occasionally dedifferentiates into high-grade carcinoma, ...resulting in poor prognoses. The dedifferentiated component is usually a poorly differentiated cribriform or solid carcinoma, whereas squamous cell carcinoma (SCC) is exceptional. Herein, we report the case of a 78-year-old woman with vulvar ACC, including an SCC component. She presented with a vulvar nodule that had been present for 30 years and increased in size over the past few years. Magnetic resonance imaging showed a ball-like mass with high intensity on T1-weighted images and high intensity with non-uniformity on T2-weighted images. Considering the systemic and social conditions, the tumor was maximally resected without lymphadenectomy. Histologically, the tumor was composed of a marginal ACC component with a central SCC component. Stage IB vulvar cancer, which was assumed to originate from the Bartholin’s gland, was diagnosed. She has survived over 2 years without additional treatments after the surgery. In this case, we assumed that slowly progressive indolent ACC could be dedifferentiated to high- grade SCC. According to our review of available literature, dedifferentiation of vulvar ACC with a high-grade SCC component has not been specifically documented. Although the nature of dedifferentiated vulvar cancer is unclear, it should be noted that high-grade dedifferentiation can occur in long-lasting vulvar masses.
FMS‐like tyrosine kinase 3 (FLT3) plays a key role in hematopoiesis. However, the oncogenic role of FLT3 amplification in patients with metastatic colorectal cancer (mCRC) remains unclear. Here, we ...aimed to evaluate the characteristics, prognosis, and treatment efficacy of an FLT3 inhibitor (regorafenib) in patients with mCRC with FLT3 amplifications. Tumor tissue samples from 2329 patients were sequenced using NGS in the Nationwide Cancer Genome Screening Project in Japan. The effects of clinicopathological features, co‐altered genes, prognosis, and efficacy of regorafenib were investigated. Between April 2015 and June 2018, 85 patients with mCRC with FLT3 amplification were observed. There were no differences in baseline characteristics between patients with or without FLT3 amplification. The frequency of RAS or other gene co‐alterations was inversely correlated with the copy number status. Median survival time in patients with FLT3 amplification was significantly shorter compared with those with non‐FLT3 amplification. Further investigations of FLT3 amplification as a potential treatment target in mCRC are warranted.
High FLT3 amplification may function not only as a prognostic factor but a promising treatment target in metastatic colorectal cancer.
The patient was a 70-year-old man with idiopathic orbital inflammation (IOI) that appeared on the severely affected side of preceding myasthenia gravis (MG). The patient was diagnosed with MG 5 years ...prior to the onset of IOI. When IOI was diagnosed, an edrophonium test was negative. IOI was considered because he complained of left orbital pain, eyelid swelling, and cerebral MRI exhibited the enhanced lesions along the left orbital periosteum. A biopsy specimen revealed pathological findings compatible with IOI. The administration of corticosteroids was effective for improving the ocular symptoms. IOI should be considered when ocular symptoms deteriorated with soft tissue swelling/pain in MG patients.
•Usage of real-world data (RWD) for clinical implementation is gaining popularity.•Use of SCRUM-Japan Registry for the phase II TRIUMPH study was investigated•We've paved way for RWD approval in ...Japan•Future steps for building regulatory-grade registries and using RWD must be defined
Utilizing real-world data (RWD) for effective clinical implementation is becoming more and more appealing as the cost of drug development rises, especially for patients with rare diseases and rare molecular subtypes for whom conducting randomized controlled trials is challenging. If a regulatory approval methodology based on RWD as an external control group can be established, drug development for rarer fractions can be accelerated by lowering costs and time, as well as reducing physical and emotional burdens on both patients and healthcare professionals. Since 2017, we have been prospectively collecting the clinical data of standard therapies in patients with rare molecular fractions under the SCRUM-Japan Registry platform, which is a qualified registry utilized as external control data for regulatory submission. Based on the results of the phase II TRIUMPH study (UMIN000027887) and the extracted data from the SCRUM-Japan Registry, the pharmaceutical company submitted an application for pertuzumab and trastuzumab in patients with HER2-positive metastatic colorectal cancer in April 2021. Pertuzumab and trastuzumab were approved as expanded indications on March 28, 2022, as 6 cases out of 14 extracted from the SCRUM-Japan Registry were classified and utilized as “evaluation material” under the review process of the Pharmaceuticals and Medical Devices Agency (PMDA). Through the TRIUMPH study and the SCRUM-Japan Registry, we have paved the way for regulatory approval of RWD in Japan. In future, we must define the steps for constructing regulatory-grade registries and the method/process for utilizing RWD by accumulating case experiences.
Keratinocytes are the main targets of infiltrating T cells in the pathogenesis of lichen planus. However, the mechanisms of dense inflammatory infiltrates beneath the epidermis remain unknown. The ...aim of the present study was to clarify the roles of programmed cell death 1 (PD‐1) and its ligand (PD‐L1) in the pathogenesis of lichen planus. Immunohistochemistry of PD‐1 and PD‐L1 in 12 cases each of lichen planus and dermal‐type erythema multiforme was performed. The expression of PD‐1 and PD‐L1 on infiltrating inflammatory cells, predominantly lymphocytes in lichen planus, was significantly less compared to that in dermal‐type erythema multiforme. By dual immunofluorescence, the overlap between PD‐1 and leukocyte common antigen, CD4, CD8, CD68, and factor XIIIa was limited and found in only a very small portion of lichen planus cells. Our data suggest that decreased expression of PD‐1 and PD‐L1 could play a role in accelerating inflammatory cell infiltration targeting the epidermis in the pathogenesis of lichen planus.
We report a case of cutaneous squamous cell carcinoma (CSCC), initially coexisting with invasive extramammary Paget's disease (EMPD), in the scrotum of an 84‐year‐old man. The patient initially had a ...rash and pruritus before presenting with a pedunculated scrotal mass surrounded by widespread erythema. He underwent total gastrectomy for adenocarcinoma 1 year previously and had been receiving TS‐1 (Tegafur/Gimeracil/Oteracil pottasium) orally. Histopathologically, the tumor consisted of invasive SCC, with invasive EMPD in the erythematous region. From the clinical presentation and histopathological findings, we assumed that CSCC developed in the background of the EMPD. The CSCC metastasized to several inguinal lymph nodes and to the brain in the following years. While the histogenesis of each of the tumors remains to be elucidated, the fact that the CSCC rather than the EMPD metastasized to a distant site in this patient is to be noted for future treatment considerations.
PDF
